Regulatory Coordinator - Madison, United States - University of Wisconsin–Madison

Mark Lane

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Mark Lane

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Description

Job Summary:

The Department of Pediatrics' leadership, faculty, and staff value and prioritize inclusion, diversity, equity, access, and anti
- racism. As such, the person in this role will support investigators with incorporating research strategies and methods that enhance these values in all aspects of study design and implementation.

This position is an opportunity to join a growing department with a vibrant research program.

Over the last decade, the University of Wisconsin Department of Pediatrics has undergone an impressive period of expansion and prosperity within all of its missions (education, research, clinical, outreach).

In fiscal year 2023, the faculty and researchers in the Department of Pediatrics received over $55 million in research support, of which nearly $37 million was NIH-funded - this is the largest total award amount in the department's history.

Of the department's 200+ current faculty members, approximately 1/3 serve as principal investigator on over 170 funded research projects spanning the department's 16 specialties.

As such, there are ample opportunities for gaining new knowledge and experiences in a collaborative environment.

  • 5% Develops clear and accurate informed consent documents
  • 15% Maintains complete and accurate regulatory files and records
  • 5% Communicates directly with protocol sponsors related to regulatory documents and activities
  • 20% Provides guidance and direction to research teams regarding compliance with policies, procedures, and regulations
  • 5% Performs quality checks
  • 5% May lead and train other staff
  • 5% Contributes to the development of new team and unit processes, procedures, tools, and training

Institutional Statement on Diversity:

Diversity is a source of strength, creativity, and innovation for UW-Madison.

We value the contributions of each person and respect the profound ways their identity, culture, background, experience, status, abilities, and opinion enrich the university community.

We commit ourselves to the pursuit of excellence in teaching, research, outreach, and diversity as inextricably linked goals.


The University of Wisconsin-Madison fulfills its public mission by creating a welcoming and inclusive community for people from every background - people who as students, faculty, and staff serve Wisconsin and the world.


Education:

Preferred
Bachelor's Degree


Qualifications:


Required Qualifications:

  • Effective oral and written communication skills, independent problem solving and analytical skills, attention to detail and organization

Preferred Qualifications:

  • Experience with Institutional Review Board (IRB) submissions or equivalent types of submissions
  • Experience with relevant software systems, such as or equivalent to: REDCap, ARROW, other electronic IRB systems, OnCore, HealthLink, Microsoft Office Suite, Adobe Acrobat, and filesharing systems such as Google Drive or Box

Additional Knowledge, Skills & Abilities:

  • Excellent organizational and prioritizations skills, including the ability to manage multiple projects
  • Knowledge and commitment to advance inclusion, diversity, equity, access, and antiracism in all aspects of the department's research endeavors
  • Indepth understanding of and/or willing and able to learn about clinical research principles and specific study and institutional guidelines
  • Ability to effectively support investigators and study teams with a serviceoriented approach

Work Type:

Full or Part Time: 80% - 100%

This position may require some work to be performed in-person, onsite, at a designated campus work location. Some work may be performed remotely, at an offsite, non-campus work location.


Appointment Type, Duration:

Ongoing/Renewable


Salary:


Minimum $55,000 ANNUAL (12 months)
Depending on Qualifications


Additional Information:

University sponsorship is not available for this position.

The selected applicant will be responsible for ensuring their continuous eligibility for employment in the United States on or before the effective date of the appointment.

UW-Madison is not an E-Verify employer, and therefore, is not eligible to employ F1-OPT STEM Extension participants.


How to Apply:


Contact:

Kelsey Scholtens

Relay Access (WTRS): See RELAY_SERVICE for further information.


Official Title:

Regulatory Coordinator(CP085)


Department(s):

A53-MEDICAL SCHOOL/PEDIATRICS/PEDIATRICS


Employment Class:

Academic Staff-Renewable


Job Number:

296292-AS


The University of Wisconsin-Madison is an Equal Opportunity and Affirmative Action Employer
:

Qualified applicants will receive consideration for employment without regard to, including but not limited to, race, color, religion, sex, sexual orientation, gender identity, national origin, age, pregnancy, disability, or status as a protected veteran and other bases as defined by federal regulations and UW System policies.

We promote excellence through diversity and en

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